Otitis externa is a disease of the external ear that is characterized by inflammation of the meatal skin. Over 90% of cases of otitis externa can be traced to bacterial and/or fungal infections. In the incipient stage, symptoms of otitis include itching and pain in the ear canal, often accompanied by tenderness in the area around the external auditory meatus and pain when the ear lobe is pulled or when the jaw is moved. In the definitive stage, suppuration occurs in the ear canal, and may be accompanied by decreased auditory function. Treatment of otitis externa is complicated by the relative inaccessibility of the infected meatal skin, which makes it difficult to effectively apply a treatment to the affected area.
One of the most common types of otitis externa encountered by physicians is a type designated as “swimmer's ear”. Swimmer's ear has long been understood in the medical arts to be an infection of bacterial etymology, and is treated accordingly. Hence, current medical practice for the treatment of swimmer's ear prescribes a multiple dose, antibiotic ear drop regiment for the treatment of this condition. In some cases, these drops may include a small dosage of a steroid or an organic acid, such as acetic acid. Typically, the ear drops are applied to the infected ear two times a day for 10 days. This approach is consistent with standard medical practice in the treatment of bacterial infections, which seeks to eradicate the causal bacteria by (a) utilizing daily dosing so as to maintain a high level of an antibiotic in the patient's bloodstream, and (b) maintaining local contact over an extended period of time.
While an eardrop regimen may be an effective treatment for swimmer's ear in some cases, and offers the considerable convenience of being able to be administered by the patient, any interruption of the treatment which results in missed dosages or applications may result in failure to cure the disease. Moreover, the topical application of eardrops often results in inadequate physical contact with the surfaces to be treated, and even when proper contact is made, such contact may be of an insufficient duration to achieve the desired physiological effect. Moreover, current eardrop formulations are found to be ineffective in a significant number of cases, even if they are properly administered.
The effectiveness of an eardrop regimen, or of any other treatment requiring periodic application of a pharmaceutical composition, can often be optimized when practiced by a skilled physician. However, as a practical matter, many patients are unwilling to participate in treatments that require multiple visits to a hospital or healthcare provider. Consequently, a number of such patients avoid initial treatment or follow-up treatments, with the result that a readily curable condition of otitis externa matures into a more acute condition requiring serious medical intervention. A similar result may occur if there is any significant delay between the occurrence of the initial symptoms and subsequent treatment, as a result of, for example, a delay in scheduling an office visit. In this respect, it is notable that the growth rate of infecting organisms in diseased tissues is often exponential.
Alternative methods have been developed in the art for treating swimmer's ear and other types of otitis externa, frequently with an object of overcoming one or more of the aforementioned infirmities. Some of these treatments may be used in conjunction with an eardrop regimen. For example, one approach involves introducing into the infected area a ribbon gauze dressing soaked with antibacterial ear drops (the ear drops may contain a small dosage of a steroid) or with an astringent such as aluminum acetate solution. While such an approach may be very effective in some cases, it is not practical in many of the more acute instances of otitis externa, since contact between the inserted gauze and the inflamed meatal tissues can be extremely painful. Moreover, this approach cannot be administered by the patient, and hence requires the patient to visit a physician for the treatment.
There is thus a need in the art for a method for treating otitis externa which does not require multiple applications, which is ameniable to treatment without delay, and which is effective in treating swimmer's ear and other types of otitis externa. There is further a need in the art for a method for treating otitis externa which is non-invasive, which can be administered by the patient, and which effectively contacts the infected meatal skin. These and other needs are met by the devices and methodologies disclosed herein and hereinafter described.